IVENA VASCULAR PATCH

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Ivena Vascular Patch.

Pre-market Notification Details

Device IDK060396
510k NumberK060396
Device Name:IVENA VASCULAR PATCH
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactJoseph P De Paolo
CorrespondentJoseph P De Paolo
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-15
Decision Date2006-05-12

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